Validated Delivery: CI/CD Under GxP Change Control
The validation auditor asked for the change record behind a production change made two weeks earlier. The honest answer was a Slack thread, a terraform apply from someone’s laptop, and a Jira ticket with no attachments. None of that is a change record.
Read MoreThe ALCOA+ Field Guide for Platform Engineers
The auditor asked a simple question: “How do you know this file was not modified after upload?” The team had versioning off, a shared transfer credential, and a fourteen-second silence that felt much longer.
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